BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 4250596 · Received November 14, 2014

    Report

    Report Number
    3005075853-2014-07909
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 27, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: HOW WAS THE LEAK DETECTED? WHAT COLOR CARTRIDGES WERE USED? HOW WAS THE REMNANT CREATED? WHAT WAS THE OBSERVED STAPLE FORM AT REOPERATION? WHAT WERE THE PATIENT¿S PRE-OP DIAGNOSIS AND/OR PRE-EXISTING CONDITIONS THAT COULD HAVE IMPACTED THE PATIENT¿S HEALTH/SURGICAL OUTCOME? HAS THE PATIENT UNDERGONE CHEMO/RADIATION THERAPY?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OP OF A BOWEL RESECTION PROCEDURE THE SURGEON SHARED INFORMATION WITH THE SALES REPRESENTATIVE CONCERNING A PATIENT THAT DEVELOPED A POST-OP LEAK. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME AS TO WHEN THE ORIGINAL SURGERY WAS COMPLETED OR DATE WHEN THE LEAK OCCURRED. NO PATIENT INFORMATION WAS PROVIDED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736931 PROXIMATE LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1